Advanced Pharma Recalls Hydromorphone Syringes Due to Sterility Concerns
Advanced Pharma Inc. is recalling 2,400 syringes of Hydromorphone HCl injectable solution nationwide due to a lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.
Plain-English summary
Advanced Pharma Inc. is recalling 2,400 syringes of HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution. The product is distributed in sterile single-use syringes with the NDC 42852-289-67. The recall is being conducted because of a lack of assurance of sterility.
The affected lots are 12/03/18 4090 28967S and 12/03/18 6221 28967S, both with an expiration date of 4/2/2019. The product was distributed nationwide. The FDA has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product and contact Advanced Pharma Inc. at (877) 794-0404 for further instructions or a return.
The recalled product
- Product
- HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-289-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Affected units
- 2,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: 12/03/18 4090 28967S Exp. 4/2/2019
- 12/03/18 6221 28967S Exp. 4/2/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Advanced Pharma Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 19 products in this recall →Related recalls
Same manufacturer · Advanced Pharma Inc.
See all →- HighAdvanced Pharma Recalls Sub-Potent Hydromorphone Injectable Solution
FDA (Drugs) · 2019-05-08
- SevereAdvanced Pharma Recalls Lidocaine Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- HighAdvanced Pharma Recalls Glycopyrrolate Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Heparin Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Phenylephrine HCl Injectable Solution Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- HighAdvanced Pharma Recalls Sub-Potent Hydromorphone Injectable Solution
FDA (Drugs) · 2019-05-08
- HighHYDROmorphone HCl 6 mg Injectable Syringes Recalled Due to Sterility Assurance Issues
FDA (Drugs) · 2024-04-03
- HighHYDROmorphone Injectable Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2024-04-03
- SevereFDA Recalls Hydromorphone Syringes Due to Sterility Concerns
FDA (Drugs) · 2017-11-01
- HighHYDROmorphone Injectable Syringes Recalled Over Sterility Assurance Issues
FDA (Drugs) · 2023-10-11
- HighHYDROmorphone Injection Syringes Recalled for Sterility Assurance Issue
FDA (Drugs) · 2024-04-03